The goal of this research is to understand whether it is practical and safe to use an intracervical balloon catheter in addition to standard of care medications at the time of an induction of labor for an abortion or fetal death. The medical device used in this study is cleared by the Food and Drug Administration (FDA) and is used for induction of labor at term gestational ages (at or above 37 weeks of gestation). The study team will also collect data about patient-level experiences with the procedure, time in labor, and labor-related complications, such as higher-than-expected blood loss or infection.
Commonly, induction of labor in the second trimester is accomplished with the use of oral anti-progestin medications (i.e., mifepristone) at least 24 hours prior to administration of sublingual, buccal, or vaginal prostaglandins (e.g., misoprostol). Innovation over the past decade has largely been focused on the concomitant use of mechanical dilation for induction of labor in order to reduce the time from initiation of labor to delivery. However, limited data exist to demonstrate the efficacy of an intracervical balloon catheter during second-trimester induction of labor. Therefore, the principal investigator seeks to conduct a feasibility randomized controlled trial to evaluate whether an intracervical balloon catheter - commonly used for inductions of labor at later gestational ages - can be used during second-trimester inductions of labor.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
The Cook Cervical Ripening Balloon is a double-balloon catheter designed to mechanically ripen the cervix prior to labor induction when the cervix is unfavorable for induction.
Number of participants diagnosed with clinical chorioamnionitis or postpartum endometritis
Maternal temperature greater than 39°C or 38-38.9°C with evidence of leukocytosis or purulent cervical drainage
Time frame: Up to 6 weeks post-delivery
Number of participants diagnosed with sepsis
Sepsis in Obstetrics Score \> 6. Score calculated from maximum maternal temperature, blood pressure, heart rate, respiratory rate, oxygen saturation, white blood cell count, and serum lactic acid
Time frame: Up to 6 weeks post-delivery
Number of participants diagnosed with septic shock
Hypotension requiring vasopressors to maintain mean arterial pressure ≥65 mm Hg and serum lactate level \>2 mmol/L (18mg/dL) despite adequate volume resuscitation
Time frame: Up to 6 weeks post-delivery
Number of participants diagnosed with postpartum hemorrhage
Estimated or quantitative blood loss greater than 1000 mL at the conclusion of expulsion of the fetus and placenta
Time frame: Up to 6 weeks post-delivery
Number of participants requiring blood transfusion after expulsion of the fetus and placenta
Time frame: Up to 6 weeks post-delivery
Number of participants requiring uterotonics
Need for misoprostol, carboprost, and/or methergine after expulsion of the fetus and/or placenta
Time frame: Up to 6 weeks post-delivery
Number of participants diagnosed with a cervical laceration
Time frame: During delivery hospitalization (within 72 hours after delivery)
Number of participants requiring adjunctive procedures in the setting of postpartum hemorrhage
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Dilation and curettage, insertion of intrauterine tamponade device (i.e., Bakri or Jada devices), uterine artery embolization, exploratory laparotomy, O'Leary and/or B-Lynch sutures, and/or other uterine-conserving surgical measures to control hemorrhage
Time frame: Up to 6 weeks post-delivery
Number of participants requiring hysterotomy or dilation and evacuation
Need for hysterotomy or dilation and evacuation in setting of failed induction of labor
Time frame: During delivery hospitalization (within the first 72 hours after admission)
Number of participants diagnosed with a uterine rupture
Time frame: Within the first 12 hours after expulsion of the fetus
Number of participants requiring intensive care unit admission
Time frame: Up to 6 weeks post-delivery
Number of participants requiring readmission to the hospital within 6 weeks of delivery
Time frame: Up to 6 weeks post-delivery
Number of participants who experience death
Time frame: Up to 6 weeks post-delivery
Patient-reported pain
Use of visual analog scale (0-10), with higher scores indicating worse levels of pain
Time frame: Up to 6 weeks post-delivery
Patient-reported distress
Impact of Event scale (0-88), with higher scores indicating higher levels of distress
Time frame: Up to 6 weeks post-delivery
Patient-reported acceptability of intervention
assessed via the question "Would you have the same procedure again if you had to have another second-trimester induction of labor?" and "Did you think the second-trimester induction of labor was better or worse than expected?"
Time frame: Up to 6 weeks post-delivery
Patient-reported satisfaction
Client Satisfaction Questionnaire-8 (8-22), with higher scores indicating higher levels of satisfaction
Time frame: During intrapartum period (up to 72 hours after delivery)
Total duration of labor, in hours
Total duration from initiation of misoprostol to expulsion of the fetus, in hours
Time frame: During intrapartum period (up to 72 hours after delivery)
Total blood loss, in milliliters
Total blood loss after expulsion of the fetus and placenta
Time frame: Within the first 24 hours after expulsion of the fetus and placenta
Number of participants requiring dilation and curettage or manual extraction of the placenta
Time frame: Within the first 12 hours after expulsion of the fetus